Clinical Evaluation of Bacitracin

Sponsor

Mekos Laboratories AS (Industry)

Overall Status

Completed

CT.gov ID

NCT00132600

Collaborator

(none)

Enrollment

Location

Duration (Months)

6.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to establish a concentration of a bacitracin-patch for diagnosing allergic contact dermatitis.

Condition or Disease	Intervention/Treatment	Phase
Allergic Contact Dermatitis	Drug: bacitracin (allergen)	Phase 2

Detailed Description

Thin-layer Rapid Use Epicutaneous Test (T.R.U.E. Test®) is a ready-to-use patch test method designed for diagnosis of allergic contact dermatitis.

The standard panel consists of two tape strips, panel 1, with 11 allergen patches and a negative control and panel 2, with 12 allergen patches. T.R.U.E. TestTM panels 1 and 2 contain 23 of the most frequent contact allergens. With the 23 allergens the test currently consists of, it is possible to detect about 60-70% of contact allergic reactions. Thus, there is a need for expanding the number of allergens included in T.R.U.E.Test in order to detect more contact allergic reactions. Bacitracin is one of these allergens, and the purpose of this study is to determine a concentration for the patch by using a bacitracin dilution series.

Study Design

Study Type:

Interventional

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

Double

Primary Purpose:

Diagnostic

Official Title:

Clinical Evaluation of Bacitracin. A Phase II Dose-Response Study

Study Start Date :

Apr 1, 2005

Study Completion Date :

Jul 1, 2005

Outcome Measures

Primary Outcome Measures

Skin reaction to the patch test after 72-96 hours and after 7 days []

Secondary Outcome Measures

Evaluation of safety including late and persistent responses []
Evaluation day 3/4, day 7 and day 21 []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Positive bacitracin patch test within the latest 5 years.
Age greater than or equal to 18 years.
Signed informed consent.

Exclusion Criteria:

Topical treatment with corticosteroids or immunosuppressives during the latest 7 days on the test area or near the test area.
Systemic treatment with corticosteroids or immunosuppressives during the latest 7 days.
Treatment with ultraviolet (UV)-light during the latest 3 weeks.
Widespread active dermatitis or dermatitis on test area.
Breast-feeding or pregnancy. Females of childbearing potential must demonstrate a negative pregnancy test before inclusion in the study.
Subjects not able to cooperate.